Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening

NCT01550783 | Completed DMC

• 3 other identifiers: 7489NCI-2013-00745R01CA157469
• Study Type: interventional
• Target: 1,335
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized clinical trial studies home-based HPV or clinic-based Pap screening for cervical cancer. It is not yet known whether home-based screening is more effective, cost-effective, and/or acceptable than clinic-based screening for cervical cancer.

Conditions

Atypical Squamous Cell of Undetermined Significance; Cervical Carcinoma; Cervical Intraepithelial Neoplasia Grade 2/3; Health Status Unknown; Human Papillomavirus Infection; Low Grade Cervical Squamous Intraepithelial Neoplasia; Stage 0 Cervical Cancer

Keywords

Cervical cancer; Atypical squamous cells of undetermined significance; Stage 0 cervical cancer; Cervical intraepithelial neoplasia grade 1; Cervical; intraepithelial neoplasia grade 2; Cervical intraepithelial neoplasia grade 3; Human papillomavirus; HPV

Outcome Measures

Primary Outcomes (7)

• Cost-effectiveness in the novel approach in vaccinated and unvaccinated women less than 30 years old

  Up to 4 years

• Cost-effectiveness in the standard approach in vaccinated and unvaccinated women less than 30 years old

  Up to 4 years

• Overall cost-effectiveness and acceptability

  The results from the trial (sensitivity, specificity, and costs) will be used in conjunction with a Markov model to determine cost per LY and cost per QALY. Model outcomes (per 100,000 screened) will include the expected numbers of false-positive test results, colposcopies, cases of CIN 1+, cases of cancer, cancer deaths, life expectancy and quality adjusted life-expectancy. Strategies will be compared using incremental cost-effectiveness ratios. Costs and outcomes will be discounted at 3% annually. One, 2-way and probabilistic sensitivity analyses conducted for all inputs to the models.

  Up to 4 years

• Sensitivity and specificity for CIN 1+ of currently recommended in-clinic cytology screening

  An intention-to-treat analysis, based upon the initial randomization, will be performed to evaluate differences between study arms (screening strategies). Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies using standard methodologies.

  Up to 4 years

• Sensitivity and specificity for CIN 1+ of novel home-based testing

  An intention-to-treat analysis, based upon the initial randomization, will be performed to evaluate differences between study arms (screening strategies). Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies using standard methodologies.

  Up to 4 years

• Sensitivity and specificity of the novel approach in vaccinated women less than 30 years old

  Estimates of sensitivity and specificity for detection of CIN 1+ will be calculated for the two screening strategies and the rate of disease in the 10% sample of test negative subjects in each arm will be extrapolated to the entire study group of test negative subjects in that arm when sensitivity and specificity estimates are calculated. Threshold analyses will also be conducted to identify the range for the cost of the home-based test due to inherent uncertainty

  Up to 4 years

• Sensitivity and specificity of the standard approach in vaccinated women less than 30 years old

  Estimates of sensitivity and specificity for detection of CIN 1 will be calculated for the two screening strategies and the rate of disease in the 10% sample of test negative subjects in each arm will be extrapolated to the entire study group of test negative subjects in that arm when sensitivity and specificity estimates are calculated. Threshold analyses will also be conducted to identify the range for the cost of the home-based test due to inherent uncertainty

  Up to 4 years

Study Arms (2)

Group I (home-based HPV screening)

EXPERIMENTAL

Participants collect 2 vaginal specimens using polyester swabs that are then placed in a specimen tube. Specimens are then submitted to the Harborview Medical Center clinical pathology lab. Participants with a positive HPV test result will have a Pap test. Participants with an abnormal Pap test will undergo standard of care as in Group II.

Other: Cytology Specimen Collection Procedure; Other: Questionnaire Administration; Procedure: Screening Method

Group II (clinic-based standard of care screening)

EXPERIMENTAL

Participants undergo standard of care cervical cancer screening and follow-up. That is, participants undergo Pap testing. Participants with an abnormal Pap test undergo HPV testing, colposcopy, cervical biopsy and/or ECC. Participants with cervical biopsies showing precancerous changes are offered to undergo LEEP or are referred to appropriate care.

Other: Cervical Papanicolaou Test; Other: Questionnaire Administration; Procedure: Screening Method

Interventions

Cervical Papanicolaou Test OTHER

Undergo standard of care Pap test screening

Also known as: Cervical Pap Test

Group II (clinic-based standard of care screening)

Cytology Specimen Collection Procedure OTHER

Undergo home-based HPV screening

Also known as: Cytologic Sampling

Group I (home-based HPV screening)

Questionnaire Administration OTHER

Ancillary studies

Group I (home-based HPV screening); Group II (clinic-based standard of care screening)

Screening Method PROCEDURE

Undergo standard of care Pap test screening

Group II (clinic-based standard of care screening)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent in English

You may not qualify if:

• Have had hysterectomy
• Currently pregnant
• Received treatment of cervical dysplasia with LEEP, cone biopsy, laser procedure or cryotherapy within THREE years
• Received colposcopy of cervix within TWO years
• Received Pap test within ONE year
• Immunocompromised (positive human immunodeficiency virus \[HIV\] test, transplant recipient, received chemotherapy for cancer, or taking immunosuppressant drugs)
• Decisionally impaired adults requiring a legally authorized representative

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (2)

• Feder MA, Kulasingam SL, Kiviat NB, Mao C, Nelson EJ, Winer RL, Whitham HK, Lin J, Hawes SE. Correlates of Human Papillomavirus Vaccination and Association with HPV-16 and HPV-18 DNA Detection in Young Women. J Womens Health (Larchmt). 2019 Oct;28(10):1428-1435. doi: 10.1089/jwh.2018.7340. Epub 2019 Jul 2.

  PMID: 31264912 DERIVED

• Mao C, Kulasingam SL, Whitham HK, Hawes SE, Lin J, Kiviat NB. Clinician and Patient Acceptability of Self-Collected Human Papillomavirus Testing for Cervical Cancer Screening. J Womens Health (Larchmt). 2017 Jun;26(6):609-615. doi: 10.1089/jwh.2016.5965. Epub 2017 Mar 23.

  PMID: 28332888 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections; Uterine Cervical Dysplasia; Atypical Squamous Cells of the Cervix

Interventions

Vaginal Smears; High-Throughput Screening Assays

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Morphological and Microscopic Findings

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Obstetrical and Gynecological; Surgical Procedures, Operative; Investigative Techniques; Technology, Pharmaceutical

Study Officials

• Nancy Kiviat

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: March 12, 2012
• Study Start: March 1, 2012
• Primary Completion: November 16, 2017
• Study Completion: November 16, 2017
• Last Updated: July 31, 2020

Record last verified: 2018-04

Locations

US (2)